Acne Scars, Irregular Pigmentation, Photodamage
Conditions
Brief summary
The purpose of this study is to compare the results of treatment between the side of the face treated with the RevLite Laser and the side of the face treated with a fractionated laser system.
Interventions
PROCEDURERevLite laser treatment
Electro-optic Q-Switched Nd: YAG Laser treatment
PROCEDUREFractionated Laser treatment
Sponsors
ConBio, a Cynosure Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Fitzpatrick Skin Type I-VI and Wrinkle Class I * Between the ages of 25-65 * Evidence of bilateral dyschromia
Exclusion criteria
* Pregnant, lactating, or is planning to become pregnant * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical or systemic therapy * coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy) * any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study * currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days * unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function * unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits * Accutane within 6 months * need to be exposed to artificial tanning devices or excessive sunlight during the trial * prior treatment with parenteral gold therapy * Diabetes Type 1 or 2 * does not agree to refrain from any other type of facial skin resurfacing (e.g., microdermabrasion, laser or IPL treatment, chemical peel) or injected fillers/other substances (e.g., Restylane, Botox) that might affect the treatment area for the duration of the study * artificial tanning within 1 month * (micro)dermabrasion within 3 months * other laser or IPL to the face within 6 months * chemical peel within 1 month * injectable fillers within 3 months * topical retinoids within 3 months * over-the-counter anti-aging products (e.g., those containing peptides, hyaluronic acid, or agents specifically advertised as having anti-aging or age-inhibiting properties) within 1 month * history of keloids or hypertrophic scarring * evidence of compromised wound healing * history of cold sores, chickenpox or shingles and unwilling to take a prophylactic course of Valtrex/acyclovir * allergy to acyclovir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the percentage of overall, cumulative improvement from Baseline in the appearance of wrinkles, skin tone and/or texture, pigmentation and acne scars | 3 and 6 months post final treatment |
Countries
United States
Outcome results
None listed